Pegasus Laboratories, Inc.
Form 483 issued February 24, 2023 · Pensacola, Florida
- Inspection
- Feb 20 – Feb 24, 2023
- Observations
- 4
- Pages
- 5
- FEI number
- 1038896
In short: On February 24, 2023, FDA issued a Form 483 with 4 observations to Pegasus Laboratories, Inc. in Pensacola, Florida (FEI 1038896) after an inspection that ran Feb 20 – Feb 24, 2023. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Quality system and laboratory controls account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into the failure of a batch or any of its components to…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
The calibration of instruments is not done at suitable intervals with provisions for remedial action in…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
This inspection in context
Questions about this 483
What did FDA find at Pegasus Laboratories, Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Pegasus Laboratories, Inc. inspected by FDA?
The inspection ran Feb 20 – Feb 24, 2023, and the Form 483 is dated February 24, 2023.
How do I get the full Form 483 for Pegasus Laboratories, Inc.?
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.