EMINENT Services Corporation
Form 483 issued April 28, 2025 · FREDERICK, Maryland
- Investigators
- Azeezat M. Lawal· U. Chen
- Observations
- 10
- Pages
- 21
- FEI number
- 3001701623
In short: On April 28, 2025, FDA issued a Form 483 with 10 observations to EMINENT Services Corporation in FREDERICK, Maryland (FEI 3001701623). The investigators were Azeezat M. Lawal and U. Chen. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 6 of 10 observations.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to establish written critical process parameters that could affect the critical quality attributes of the…
- 02
Failure to ensure instrumentation that is critical for assuring the quality of API is calibrated…
- 03
Written calibration procedures for laboratory instruments are deficient in that they do not include specific directions…
- 04
Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data…
This inspection in context
Azeezat M. Lawal
8 documents · 2023–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Maryland.
The firmEMINENT Services Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at EMINENT Services Corporation?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected EMINENT Services Corporation?
Azeezat M. Lawal and U. Chen are named on this Form 483. Each investigator has a profile showing what they cite most.
When was EMINENT Services Corporation inspected by FDA?
This Form 483 is dated April 28, 2025.
How do I get the full Form 483 for EMINENT Services Corporation?
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.