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FDA Warning Letter Explorer
FDA warning letter · Drugs

Natural Relief Inc.

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

You failed to establish specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.70(a). Specifically, regarding your BP NatRelief 11 and Edema NatRelief 6 products:

Passage 2

You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch for your BP NatRelief 11 and Edema NatRelief 6 products, as required by 21 CFR 111.205(a) and 21 CFR 111.210. Specifically, your master manufacturing record titled “Master Formula” is not prepared for a unique dietary supplement formulation and batch size.

Passage 3

You failed to establish a batch production record (BPR) that satisfies the requirements of 21 CFR 111.255 and 111.260. For example, the BPRs for the BP Nat Relief, 11 Lot **(b)(4)**, and Edema NatRelief 6, Lot **(b)(4)** you provided to our Investigator were missing:

Passage 4

You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you have not established written procedures for holding and distributing operations for your BP NatRelief 11 and Edema NatRelief 6 products. Once you have established written procedures for your holding and distributing operations, you must make and keep records of such written procedures, as required by 21 CFR 111.475(b)(1).

Passage 5

You failed to establish and follow written procedures for returned dietary supplements for your BP NatRelief 11 and Edema NatRelief 6 products, as required by 21 CFR 111.503. Specifically, you have no written procedures for returned dietary supplements.

Passage 6

You failed to establish and follow written procedures for maintaining, cleaning, and sanitizing, as necessary, equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components of dietary supplements for your BP NatRelief 11 and Edema NatRelief 6 products, as required by 21 CFR 111.25(c). Specifically, you did not provide any documentation to support your procedures for how you maintain, clean, and sanitize the utensils used in manufacturing processes.

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 101.9(b)
  • 21 CFR 101.12(b)
  • 21 CFR 101.36
  • 21 CFR 101.9
  • 21 CFR 101.4
  • 21 CFR 101.36(e)(1)
  • 21 CFR 101.36(c)(2)
  • 21 CFR 101.2(e)
  • 21 CFR 111.70(a)
  • 21 CFR 111.70(b)(1)
  • 21 CFR 111.70(b)(2)
  • 21 CFR 111.70(b)(3)
  • 21 CFR 111.70(c)(1)
  • 21 CFR 111.70(e)
  • 21 CFR 111.75
  • 21 CFR 111.103
  • 21 CFR 111.65
  • 21 CFR 111.205(a)
  • 21 CFR 111.210
  • 21 CFR 111.255
  • 21 CFR 111.260(f)
  • 21 CFR 111.260(k)(2)
  • 21 CFR 111.260
  • 21 CFR 111.453
  • 21 CFR 111.475(b)(1)
  • 21 CFR 111.503
  • 21 CFR 111.535(b)
  • 21 CFR 111.25(c)
  • 21 CFR 111.27(b)
  • 21 CFR 111.35(b)(3)
  • 21 CFR 111
  • 21 CFR 201.5