Pharmco Laboratories Inc.
Form 483 issued November 30, 2015 · Titusville, Florida
- Inspection
- Nov 9 – Nov 30, 2015
- Investigator
- Ileana Barreto-Pettit
- Observations
- 20
- Pages
- 10
- FEI number
- 1048788
In short: On November 30, 2015, FDA issued a Form 483 with 20 observations to Pharmco Laboratories Inc. in Titusville, Florida (FEI 1048788) after an inspection that ran Nov 9 – Nov 30, 2015. The investigator was Ileana Barreto-Pettit. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Laboratory controls and quality system account for 9 of 12 observations.
Most cited: 21 CFR 211.100 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your Quality Unit is inadequate in that roles and responsibilities are not clearly defined and written…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
The written stability program…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Ileana Barreto-Pettit
25 documents · 2001–2022
Cites 211.42 (design and construction features) 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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmco Laboratories Inc.?
FDA listed 20 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Pharmco Laboratories Inc.?
Ileana Barreto-Pettit is named on this Form 483, for the inspection of Nov 9 – Nov 30, 2015. Each investigator has a profile showing what they cite most.
When was Pharmco Laboratories Inc. inspected by FDA?
The inspection ran Nov 9 – Nov 30, 2015, and the Form 483 is dated November 30, 2015.
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.