Pharmco Laboratories Inc.
Form 483 issued September 22, 2021 · Titusville, Florida
- Inspection
- Sep 13 – Sep 22, 2021
- Investigator
- Nicole E. Knowlton
- Observations
- 10
- Pages
- 12
- FEI number
- 1048788
In short: On September 22, 2021, FDA issued a Form 483 with 10 observations to Pharmco Laboratories Inc. in Titusville, Florida (FEI 1048788) after an inspection that ran Sep 13 – Sep 22, 2021. The investigator was Nicole E. Knowlton. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Facilities & equipment and quality system account for 6 of 10 observations.
Most cited: 21 CFR 211.192 (2×) · 211.170(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…
- 04
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
Nicole E. Knowlton
36 documents · 2013–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Florida.
The firmPharmco Laboratories Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmco Laboratories Inc.?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Pharmco Laboratories Inc.?
Nicole E. Knowlton is named on this Form 483, for the inspection of Sep 13 – Sep 22, 2021. Each investigator has a profile showing what they cite most.
When was Pharmco Laboratories Inc. inspected by FDA?
The inspection ran Sep 13 – Sep 22, 2021, and the Form 483 is dated September 22, 2021.
How do I get the full Form 483 for Pharmco 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.