Belcher Pharmaceuticals, LLC
Form 483 issued May 13, 2016 · Largo, Florida
- Inspection
- Apr 25 – May 13, 2016
- Investigators
- Jennifer Lalama· Jessica L. Pressley· Miguel A. Martinez
- Observations
- 9
- Pages
- 14
- FEI number
- 1000526113
In short: On May 13, 2016, FDA issued a Form 483 with 9 observations to Belcher Pharmaceuticals, LLC in Largo, Florida (FEI 1000526113) after an inspection that ran Apr 25 – May 13, 2016. The investigators were Jennifer Lalama, Jessica L. Pressley, Miguel A. Martinez and Stephanie D. Crockett. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 7 of 9 observations.
Most cited: 21 CFR 211.160 (2×) · 211.194 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include complete records of the periodic…
- 02
The accuracy and specificity of test methods have not…
- 03
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Jennifer Lalama
31 documents · 2015–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmBelcher Pharmaceuticals, 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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Belcher Pharmaceuticals, LLC?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Belcher Pharmaceuticals, LLC?
Jennifer Lalama, Jessica L. Pressley, Miguel A. Martinez and Stephanie D. Crockett are named on this Form 483, for the inspection of Apr 25 – May 13, 2016. Each investigator has a profile showing what they cite most.
When was Belcher Pharmaceuticals, LLC inspected by FDA?
The inspection ran Apr 25 – May 13, 2016, and the Form 483 is dated May 13, 2016.
How do I get the full Form 483 for Belcher Pharmaceuticals, 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.