Lyne Laboratories
Form 483 issued March 10, 2026 · Brockton, Massachusetts
- Inspection
- Feb 11 – Mar 10, 2026
- Investigators
- Ifechimere I. Okafor· Jonathan G. Matrisciano
- Observations
- 5
- Pages
- 5
- FEI number
- 1000513191
In short: On March 10, 2026, FDA issued a Form 483 with 5 observations to Lyne Laboratories in Brockton, Massachusetts (FEI 1000513191) after an inspection that ran Feb 11 – Mar 10, 2026. The investigators were Ifechimere I. Okafor and Jonathan G. Matrisciano. Most observations concern production and facilities & equipment.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
ELPLOVEE(S) SIGNATURE Buildings used in the manufacturing and processing of a drug product are not maintained…
- 03
Representative samples are not taken of each shipment of each lot of drug product containers and…
- 04
Labeling and packaging materials are not representatively sampled, examined and tested upon receipt and before use…
This inspection in context
Ifechimere I. Okafor
5 documents · 2024–2026
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New York.
The firmLyne Laboratories history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lyne Laboratories?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Lyne Laboratories?
Ifechimere I. Okafor and Jonathan G. Matrisciano are named on this Form 483, for the inspection of Feb 11 – Mar 10, 2026. Each investigator has a profile showing what they cite most.
When was Lyne Laboratories inspected by FDA?
The inspection ran Feb 11 – Mar 10, 2026, and the Form 483 is dated March 10, 2026.
How do I get the full Form 483 for Lyne Laboratories?
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.