Akron Coating & Adhesives
Form 483 issued April 10, 2019 · Akron, Ohio
- Inspection
- Apr 3 – Apr 10, 2019
- Investigator
- Jazmine N. Still
- Observations
- 6
- Pages
- 4
- FEI number
- 3002992168
In short: On April 10, 2019, FDA issued a Form 483 with 6 observations to Akron Coating & Adhesives in Akron, Ohio (FEI 3002992168) after an inspection that ran Apr 3 – Apr 10, 2019. The investigator was Jazmine N. Still. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and materials account for 4 of 6 observations.
Most cited: 21 CFR 211.166(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The identity of each component of a drug product is not verified by conducting at least…
- 02
An adequate number of batches of each drug product are not tested to determine…
- 03
There is no written testing program designed to assess the stability…
- 04
The written stability testing…
This inspection in context
Jazmine N. Still
16 documents · 2017–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmAkron Coating & Adhesives history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Akron Coating & Adhesives?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, materials and production. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Akron Coating & Adhesives?
Jazmine N. Still is named on this Form 483, for the inspection of Apr 3 – Apr 10, 2019. Each investigator has a profile showing what they cite most.
When was Akron Coating & Adhesives inspected by FDA?
The inspection ran Apr 3 – Apr 10, 2019, and the Form 483 is dated April 10, 2019.
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.