Atlas

FDA Investigator

Damaris Y Hernandez, FDA Investigator

Also appears on FDA documents as Damaris Hernandez, Damaris Y. Hernandez, Hernandez, Damaris Y.

Human DrugsAnimal Drugs & FeedsFoods & CosmeticsMedical Devices & Rad Health

FDA inspection record · Last updated August 15, 2026

Overview

  • 34 inspections across 34 sites are on record.
  • 81 Form 483 observations are attributed to this investigator.
  • Most recent recorded activity is 2026-05-29.

About Damaris Hernandez

Damaris Y Hernandez, also listed on FDA documents as Damaris Hernandez, is an FDA investigator with 34 inspections at 34 sites and 81 Form 483 observations on record between March 2022 and May 2026. The published record holds 15 of the resulting Form 483s; 13 are for human drug facilities, one for a device maker and one for an animal drug manufacturer.

The base is Florida. Eight of the 15 forms went to Florida facilities in Tamarac, Miami Lakes, Miami Gardens, Orlando, Tampa, Titusville, Melbourne and Fort Myers, among them Pharmco Laboratories in Titusville and Ultrum Labs in Tampa. Foreign assignments include Samchundang Pharm in Hwaseong, South Korea in May 2026, Seasons Biotechnology in Taizhou, China, and Uniao Quimica in Guarulhos, Brazil.

The forms run longer than average: 5.4 observations per 483, with 16 on a 2024 form to The Richline Group and nine on Natural Technology the same year. 21 CFR 211.22(d), quality unit procedures not written or not followed, appears on six of the 13 forms with structured citations, more than any other section. Nicole E Knowlton co-signed three of them. Our guide to FDA investigators and their inspection history explains how to use a record like this before an inspection.

At a glance

Inspections

34

Sites

34

Observations

81

Career since

Mar 2022

Form 483s on record

Every Form 483 in the published record that names Damaris Y Hernandez, most recent first.

IssuedCompany and facilityCategoryObservations
19 May 2026Samchundang Pharm Co., Ltd.Hwaseong, South KoreaHuman Drugs8
17 Jun 2025Glenmark Pharmaceuticals Inc USAMonroe, United StatesHuman Drugs5
24 Apr 2025Absolutely NaturalMelbourne, United StatesHuman Drugs5
20 Mar 2025Pharmco Laboratories Inc.Titusville, United StatesHuman Drugs6
20 Sep 2024Salon Technologies International, IncOrlando, United StatesHuman Drugs3
3 Apr 2024Seasons Biotechnology (Taizhou) Co., Ltd.Taizhou, ChinaHuman Drugs1
1 Mar 2024NATURAL TECHNOLOGY, LLCTerrell, United StatesHuman Drugs9
12 Jan 2024The Richline Group IncTamarac, United StatesMedical Devices & Rad Health16
16 Oct 2023Ultrum Labs, LLCTampa, United StatesHuman Drugs6
9 Aug 2023Unio Qumica Farmacutica Nacional SAGuarulhos, BrazilAnimal Drugs & Feeds2
31 Oct 2022Chemco CorporationMiami Lakes, United StatesHuman Drugs5
2 Sep 2022PAI Holdings, LLC, dba Pharmaceutical Associates, IncGreenville, United StatesHuman Drugs3
22 Jul 2022Tarmac Products, Inc.Miami Gardens, United StatesHuman Drugs5
16 Jun 2022QuVa Pharma, Inc.Temple, United StatesHuman Drugs3
30 Mar 2022Klocke of America, Inc.Fort Myers, United StatesHuman Drugs4

Regulations cited most

How many of Damaris Y Hernandez's Form 483s cite each section of the Code of Federal Regulations.

RegulationWhat it coversForm 483s citing it
21 CFR 211.22(d)Responsibilities of the quality control unit6
21 CFR 211.160(b)Laboratory controls, general requirements2
21 CFR 211.192Production record review and investigation of discrepancies2
21 CFR 211.100(a)Written production and process control procedures2
21 CFR 211.113(b)Control of microbiological contamination1
21 CFR 211.25(a)Personnel qualifications1
21 CFR 211.165(e)Testing and release for distribution1
21 CFR 211.67(b)(2)Equipment cleaning and maintenance1

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
Aqualex Co., Ltd.29 May 2026Human DrugsOn file
Samchundang Pharm Co., Ltd.19 May 2026Human DrugsView 483 →
Bausch & Lomb Incorporated20 Mar 2026Human DrugsOn file
Catalent Pharma Solutions, LLC30 Jan 2026Human DrugsOn file
KRS PHARMACEUTICALS PRIVATE LIMITED21 Nov 2025Human DrugsOn file

Sites inspected

Aqualex Co., Ltd.Seongnam, Korea (the Republic of)1 insp.
Samchundang Pharm Co., Ltd.Hwaseong, Korea (the Republic of)1 insp.
Bausch & Lomb IncorporatedTampa, United States1 insp.
Catalent Pharma Solutions, LLCSaint Petersburg, United States1 insp.
KRS PHARMACEUTICALS PRIVATE LIMITEDAnakapalli, India1 insp.

Co-investigators

Investigators who co-signed a Form 483 with Damaris Y Hernandez.

Full investigator report

Get the verbatim findings behind Damaris Y Hernandez's 81 observations

Source 483 PDFs, verbatim observations, and how each site responded, so your team knows what they cite before they arrive.

  • New inspections and Form 483s, mapped to the CFR citation
  • Warning letter outcomes, and the citation patterns they repeat
  • Their co-investigators, so no surprises about who shows up on site

FAQ

Questions about FDA investigator Damaris Hernandez

Answers drawn from Damaris Y Hernandez's inspection and Form 483 record.

Who is Damaris Hernandez at the FDA?

Damaris Y Hernandez is an FDA investigator with 34 inspections at 34 sites since March 2022 and 81 Form 483 observations on record. Most of the inspections are of drug and over-the-counter manufacturers in Florida, with others in Texas, North Carolina, South Carolina, South Korea, China and Brazil. The most recent inspection on record was in South Korea in May 2026.

How many Form 483s has Damaris Y Hernandez issued?

The published record holds 15 Form 483s that name Damaris Y Hernandez, issued between March 2022 and May 2026. They average 5.4 observations, above the industry median of three, and the longest carried 16, to The Richline Group in Tamarac, Florida in January 2024. Each form is listed in the table above.

What does Damaris Hernandez cite most on Form 483s?

21 CFR 211.22(d), quality unit procedures that are not written or not followed, appears on six of the 13 Damaris Hernandez Form 483s with structured citations. Laboratory controls under 211.160(b), investigations under 211.192 and production procedures under 211.100(a) follow, each on two forms.

Which companies has Damaris Hernandez inspected?

Companies with a Form 483 from Damaris Hernandez include Samchundang Pharm in Hwaseong, South Korea, Glenmark Pharmaceuticals in Monroe, North Carolina, Pharmco Laboratories in Titusville, Ultrum Labs in Tampa, QuVa Pharma in Temple, Texas and Pharmaceutical Associates in Greenville, South Carolina. The full list is in the table above.

Who does Damaris Hernandez inspect with?

Nicole E Knowlton co-signed three Damaris Hernandez Form 483s, more than any other investigator. Others who co-signed one each include Khoa Nathan V Tran, Steven A Brettler and Marian E Ramirez.