Greer Laboratories, Inc.
Form 483 issued August 27, 2015 · Lenoir, North Carolina
- Inspection
- Aug 27, 2015
- Investigators
- Burnell M. Henry· Cynthia Jim
- Observations
- 11
- Pages
- 9
- FEI number
- 1011574
In short: On August 27, 2015, FDA issued a Form 483 with 11 observations to Greer Laboratories, Inc. in Lenoir, North Carolina (FEI 1011574) after an inspection that ran Aug 27, 2015. The investigators were Burnell M. Henry and Cynthia Jim. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 7 of 11 observations.
Most cited: 21 CFR 211.113 (4×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An appropriately identified reserve sample(s), representative of each lot or batch of product is not retained…
- 02
Changes were implemented without supplement submission and approval prior to distribution of the product. The test…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Facilities designed to prevent contamination are deficient regarding operations related to aseptic processing of drug products…
This inspection in context
Burnell M. Henry
22 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in North Carolina.
The firmGreer Laboratories, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Greer Laboratories, Inc.?
FDA listed 11 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Greer Laboratories, Inc.?
Burnell M. Henry and Cynthia Jim are named on this Form 483, for the inspection of Aug 27, 2015. Each investigator has a profile showing what they cite most.
When was Greer Laboratories, Inc. inspected by FDA?
The inspection ran Aug 27, 2015, and the Form 483 is dated August 27, 2015.
How do I get the full Form 483 for Greer 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.