Pharmaceutic Labs, LLC
Form 483 issued September 23, 2015 · Albany, New York
- Inspection
- Aug 31 – Sep 23, 2015
- Investigator
- Chad N. Thompson
- Observations
- 6
- Pages
- 3
- FEI number
- 3010750417
In short: On September 23, 2015, FDA issued a Form 483 with 6 observations to Pharmaceutic Labs, LLC in Albany, New York (FEI 3010750417) after an inspection that ran Aug 31 – Sep 23, 2015. The investigator was Chad N. Thompson. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Clothing of personnel engaged in the ofdrug products is not appropriate for…
- 03
Test procedures relative to appropriate laboratory testing for…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
This inspection in context
Chad N. Thompson
7 documents · 2013–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmPharmaceutic Labs, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmaceutic Labs, LLC?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Pharmaceutic Labs, LLC?
Chad N. Thompson is named on this Form 483, for the inspection of Aug 31 – Sep 23, 2015. Each investigator has a profile showing what they cite most.
When was Pharmaceutic Labs, LLC inspected by FDA?
The inspection ran Aug 31 – Sep 23, 2015, and the Form 483 is dated September 23, 2015.
How do I get the full Form 483 for Pharmaceutic Labs, LLC?
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.