Akron Coating & Adhesives
Form 483 issued June 27, 2022 · Akron, Ohio
- Inspection
- Jun 21 – Jun 27, 2022
- Observations
- 8
- Pages
- 7
- FEI number
- 3002992168
In short: On June 27, 2022, FDA issued a Form 483 with 8 observations to Akron Coating & Adhesives in Akron, Ohio (FEI 3002992168) after an inspection that ran Jun 21 – Jun 27, 2022. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and production account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
The written stability program does not assure testing of the drug product in the same container-closure…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
The written stability program for drug products does not include reliable, meaningful…
This inspection in context
Questions about this 483
What did FDA find at Akron Coating & Adhesives?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
When was Akron Coating & Adhesives inspected by FDA?
The inspection ran Jun 21 – Jun 27, 2022, and the Form 483 is dated June 27, 2022.
How do I get the full Form 483 for Akron Coating & Adhesives?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.