Aetna Felt Corporation
Form 483 issued May 13, 2021 · Allentown, Pennsylvania
- Inspection
- May 12 – May 13, 2021
- Investigators
- Craig D. Zagata· Rachael O. Oyewole
- Observations
- 5
- Pages
- 2
- FEI number
- 1000136193
In short: On May 13, 2021, FDA issued a Form 483 with 5 observations to Aetna Felt Corporation in Allentown, Pennsylvania (FEI 1000136193) after an inspection that ran May 12 – May 13, 2021. The investigators were Craig D. Zagata and Rachael O. Oyewole. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP…
This inspection in context
Craig D. Zagata
11 documents · 2016–2021
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmAetna Felt Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aetna Felt Corporation?
FDA listed 5 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Aetna Felt Corporation?
Craig D. Zagata and Rachael O. Oyewole are named on this Form 483, for the inspection of May 12 – May 13, 2021. Each investigator has a profile showing what they cite most.
When was Aetna Felt Corporation inspected by FDA?
The inspection ran May 12 – May 13, 2021, and the Form 483 is dated May 13, 2021.
How do I get the full Form 483 for Aetna Felt Corporation?
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.