Regulatory Open Forum

An EIR is just the investigators report to the office of compliance on the inspection findings.  It is normally for internal use.  A 483 will be prepared if deficiencies are found that require correction.  That will be sent to the person who was head of office for the inspection, or the designee.

Someone said you don't need to respond to a 483.  That is not correct.  You must address each and every deficiency cited in a 483.  If the 483 cites quality related issues, you must address what the implications are to you system as well.  You must provide a reasonable time frame for addressing and completing each deficiency along with any applicable pertinent documentation, not band-aid solutions.  Inadequate response to a 483 can and will likely lead to a warning letter.  483's are not available under FOI, but warning letters become public knowledge.

An EIR is just the investigators report to the office of compliance on the inspection findings.  It is normally for internal use.  A 483 will be prepared if deficiencies are found that require correction.  That will be sent to the person who was head of office for the inspection, or the designee.

Someone said you don't need to respond to a 483.  That is not correct.  You must address each and every deficiency cited in a 483.  If the 483 cites quality related issues, you must address what the implications are to you system as well.  You must provide a reasonable time frame for addressing and completing each deficiency along with any applicable pertinent documentation, not band-aid solutions.  Inadequate response to a 483 can and will likely lead to a warning letter.  483's are not available under FOI, but warning letters become public knowledge.

An EIR is just the investigators report to the office of compliance on the inspection findings.  It is normally for internal use.  A 483 will be prepared if deficiencies are found that require correction.  That will be sent to the person who was head of office for the inspection, or the designee.

Someone said you don't need to respond to a 483.  That is not correct.  You must address each and every deficiency cited in a 483.  If the 483 cites quality related issues, you must address what the implications are to you system as well.  You must provide a reasonable time frame for addressing and completing each deficiency along with any applicable pertinent documentation, not band-aid solutions.  Inadequate response to a 483 can and will likely lead to a warning letter.  483's are not available under FOI, but warning letters become public knowledge.

Straight from the FDA Website at Procedure for Release of Establishment Inspection Report confirming that 483's and the EIR are available through FOIA.

 Under the Freedom of Information Act (FOIA) and FDA's regulations governing disclosures as set out at 21 C.F.R. Part 20, any inspection information including the list of inspectional observations (FDA-483), EIR, and the Agency's communication with the regulated establishment must be disclosed upon request by any member of the public. When requested according to established FOIA procedures, the Agency has made the inspection-related information available to requestors in accordance with the above statutory requirements. That is, the information that is not protected from disclosure by an FOIA exemption becomes releasable once the inspection is deemed closed by the Agency. Establishments wishing to obtain a copy of FDA's inspection report of their own establishment in the past were required to follow the same procedure. A number of industry associations expressed concerns that copies of EIRs may have been released to other requestors before the inspected establishments received the copies they requested. Consequently, these groups approached the Agency to request that it provide a copy of the EIR following an inspection of their facilities.

The Agency considered this request and determined that a copy of the EIR should be routinely provided to the inspected establishment once the Agency concludes that the inspection is closed. For the purpose of this directive, the term "closed" will have the same meaning as it has under 21 C.F.R. §20.64 (d)(3).

An EIR is just the investigators report to the office of compliance on the inspection findings.  It is normally for internal use.  A 483 will be prepared if deficiencies are found that require correction.  That will be sent to the person who was head of office for the inspection, or the designee.

Someone said you don't need to respond to a 483.  That is not correct.  You must address each and every deficiency cited in a 483.  If the 483 cites quality related issues, you must address what the implications are to you system as well.  You must provide a reasonable time frame for addressing and completing each deficiency along with any applicable pertinent documentation, not band-aid solutions.  Inadequate response to a 483 can and will likely lead to a warning letter.  483's are not available under FOI, but warning letters become public knowledge.

An EIR is just the investigators report to the office of compliance on the inspection findings.  It is normally for internal use.  A 483 will be prepared if deficiencies are found that require correction.  That will be sent to the person who was head of office for the inspection, or the designee.

Someone said you don't need to respond to a 483.  That is not correct.  You must address each and every deficiency cited in a 483.  If the 483 cites quality related issues, you must address what the implications are to you system as well.  You must provide a reasonable time frame for addressing and completing each deficiency along with any applicable pertinent documentation, not band-aid solutions.  Inadequate response to a 483 can and will likely lead to a warning letter.  483's are not available under FOI, but warning letters become public knowledge.

An EIR is just the investigators report to the office of compliance on the inspection findings.  It is normally for internal use.  A 483 will be prepared if deficiencies are found that require correction.  That will be sent to the person who was head of office for the inspection, or the designee.

Someone said you don't need to respond to a 483.  That is not correct.  You must address each and every deficiency cited in a 483.  If the 483 cites quality related issues, you must address what the implications are to you system as well.  You must provide a reasonable time frame for addressing and completing each deficiency along with any applicable pertinent documentation, not band-aid solutions.  Inadequate response to a 483 can and will likely lead to a warning letter.  483's are not available under FOI, but warning letters become public knowledge.

An EIR is just the investigators report to the office of compliance on the inspection findings.  It is normally for internal use.  A 483 will be prepared if deficiencies are found that require correction.  That will be sent to the person who was head of office for the inspection, or the designee.

Someone said you don't need to respond to a 483.  That is not correct.  You must address each and every deficiency cited in a 483.  If the 483 cites quality related issues, you must address what the implications are to you system as well.  You must provide a reasonable time frame for addressing and completing each deficiency along with any applicable pertinent documentation, not band-aid solutions.  Inadequate response to a 483 can and will likely lead to a warning letter.  483's are not available under FOI, but warning letters become public knowledge.