Drug factory · FDA FEI 3007410731

Dhaliwal Labs South, LLC

11910 Shiloh Rd Ste 130, Dallas, TX, United States

Problems found, fixed voluntarily at FDA's last inspection, Jun 26, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

7 drug inspections on record since 2009: 0 with no problems, 6 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Hydrocortisone	Makes it	Bioelements, Inc.	49825-126

Ended	Result	Program	Problems noted
Jun 26, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	3
Apr 25, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	2
Dec 20, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 14, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	3
Jun 20, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	3
Dec 15, 2011	Serious problems, FDA action	Drug Quality Assurance	20
Dec 8, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	15

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Written records kept in individual logs 21 CFR 211.182
Written records of major equipment cleaning and use are not included in individual equipment logs.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.

Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
Determination not to conduct investigation of complaint 21 CFR 211.198(b)(3)
The written record did not include the reason an investigation was found not to be necessary when an investigation into unexplained discrepancies was not conducted.

Samples (various types) representative, identified properly 21 CFR 211.160(b)(1)
Samples taken to determine conformance to appropriate written specifications for the acceptance of each lot within each shipment of components are not representative.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.

Review of representative number of batches 21 CFR 211.180(e)(1)
Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch.
Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.

Registered with FDA for: manufacture.